Medical Device Manufacturer · US , Fairfax , VA

Fitbit, Inc.

3 submissions · 3 cleared · Since 2014
3
Total
3
Cleared
0
Denied

Fitbit, Inc. — FDA 510(k) Submissions

Fitbit, Inc. has submitted 3 FDA 510(k) premarket notifications since 2014, of which 3 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Analyzer, Body Composition, Electrocardiograph Software For Over-the-counter Use, Photoplethysmograph Analysis Software For Over-the-counter Use . Use the specialty filter in the sidebar to narrow results.

3 devices
1–3 of 3
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